Chamith S Rajapakse1, Mary B Leonard2, Elizabeth A Kobe3, Michelle A Slinger3, Kelly A Borges3, Erica Billig4, Clinton T Rubin5, Felix W Wehrli3. 1. Department of Radiology, University of Pennsylvania, 3400 Spruce Street, 1 Founders Building, Philadelphia, PA 19104; Department of Orthopaedic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: chamith@mail.med.upenn.edu. 2. Department of Pediatrics, The Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, Pennsylvania. 3. Department of Radiology, University of Pennsylvania, 3400 Spruce Street, 1 Founders Building, Philadelphia, PA 19104. 4. Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania. 5. Department of Biomedical Engineering, Stony Brook University, Stony Brook, New York.
Abstract
RATIONAL AND OBJECTIVES:Low intensity vibration (LIV) may represent a nondrug strategy to mitigate bone deficits in patients with end-stage renal disease. MATERIALS AND METHODS:Thirty end-stage renal patients on maintenance hemodialysis were randomized to stand for 20 minutes each day on either an active or placebo LIV device. Analysis at baseline and completion of 6-month intervention included magnetic resonance imaging (tibia and fibula stiffness; trabecular thickness, number, separation, bone volume fraction, plate-to-rod ratio; and cortical bone porosity), dual-energy X-ray absorptiometry (hip and spine bone mineral density [BMD]), and peripheral quantitative computed tomography (tibia trabecular and cortical BMD; calf muscle cross-sectional area). RESULTS: Intention-to-treat analysis did not show any significant changes in outcomes associated with LIV. Subjects using the active device and with greater than the median adherence (70%) demonstrated an increase in distal tibia stiffness (5.3%), trabecular number (1.7%), BMD (2.3%), and plate-to-rod ratio (6.5%), and a decrease in trabecular separation (-1.8%). Changes in calf muscle cross-sectional area were associated with changes in distal tibia stiffness (R = 0.85), trabecular bone volume/total volume (R = 0.91), number (R = 0.92), and separation (R = -0.94) in the active group but not in the placebo group. Baseline parathyroid hormone levels were positively associated with increased cortical bone porosity over the 6-month study period in the placebo group (R = 0.55) but not in the active group (R = 0.01). No changes were observed in the nondistal tibia locations for either group except a decrease in hip BMD in the placebo group (-1.7%). CONCLUSION: Outcomes and adherence thresholds identified from this pilot study could guide future longitudinal studies involving vibration therapy.
RCT Entities:
RATIONAL AND <span class="abstract_title">OBJECTIVES: Low intensity vibration (LIV) may represent a nondrug strategy to mitigate bone deficits in patients withend-stage renal disease. MATERIALS AND METHODS:Thirty end-stage renal patients on maintenance hemodialysis were randomized to stand for 20 minutes each day on either an active or placebo LIV device. Analysis at baseline and completion of 6-month intervention included magnetic resonance imaging (tibia and fibula stiffness; trabecular thickness, number, separation, bone volume fraction, plate-to-rod ratio; and cortical bone porosity), dual-energy X-ray absorptiometry (hip and spine bone mineral density [BMD]), and peripheral quantitative computed tomography (tibia trabecular and cortical BMD; calf muscle cross-sectional area). RESULTS: Intention-to-treat analysis did not show any significant changes in outcomes associated with LIV. Subjects using the active device and with greater than the median adherence (70%) demonstrated an increase in distal tibia stiffness (5.3%), trabecular number (1.7%), BMD (2.3%), and plate-to-rod ratio (6.5%), and a decrease in trabecular separation (-1.8%). Changes in calf muscle cross-sectional area were associated with changes in distal tibia stiffness (R = 0.85), trabecular bone volume/total volume (R = 0.91), number (R = 0.92), and separation (R = -0.94) in the active group but not in the placebo group. Baseline parathyroid hormone levels were positively associated with increased cortical bone porosity over the 6-month study period in the placebo group (R = 0.55) but not in the active group (R = 0.01). No changes were observed in the nondistal tibia locations for either group except a decrease in hip BMD in the placebo group (-1.7%). CONCLUSION: Outcomes and adherence thresholds identified from this pilot study could guide future longitudinal studies involving vibration therapy.
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Authors: Irene Ruderman; Chamith S Rajapakse; Angelica Opperman; Patricia L Robertson; Rosemary Masterson; Mark K Tiong; Nigel D Toussaint Journal: Bone Rep Date: 2020-07-15
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